Leachables and extractables studies mainly concern materials that are a part of a manufacturing equipment or a packaging.
QualiMetrix provides integrated analytical services and product development for the pharmaceutical industry.
The company offers support throughout formula development, product registration and post-marketing stages, while its analytical offerings include quality control (QC) testing and research and development (R&D) studies. All of company’s studies are performed using state-of-the-art instrumentation that is consistently updated.
QualiMetrix’s contract laboratory meets the stringent regulatory requirements of the healthcare industry, performing consistently to good manufacturing practice (GMP) and good laboratory practice (GLP) standards.
Analytical and pharmaceutical development services
QualiMetrix supports the development and optimisation of pharmaceutical composition, manufacturing processes and specifications.
The company also provides an integrated package of development and analytical method validation. In the premises there is under operation a wide range of analytical instrumentation, which covers any pharmacopoeia or non-pharmacopoeia test, including high-performance liquid chromatography (HPLC), ultra-high-performance liquid chromatography (UPLC), head space gas chromatography (GC), dissolution apparatus I-IV, tandem mass spectrometry (MS/MS) triple quadrupole, ion trap-orbitrap and inductively coupled plasma mass spectrometry (ICP-MS).
Batch testing and release for API and final products
QualiMetrix performs testing and releasing of active pharmaceutical ingredients (API), excipients, packaging and final products, which include all pharmaceutical forms and high-potent drugs
Stability and photostability studies meeting ICH guidelines
QualiMetrix’s comprehensive stability testing services are conducted according to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines.
The stability study protocols meet quality procedures and GMP requirements and are available for all climatic zones from I to IVb.
The chambers are temperature and humidity controlled and are connected to a 24-hour alarm system. Photostability testing is based on fluorescent light source under controlled conditions according to option 2 of the ICH Q1B guideline.
Scientific guidance is provided for the study design (such as full design, bracketing or matrixing reduced design), as well as to the statistical evaluation of the stability data.
Leachables and extractables studies for packaging and manufacturing materials
Polymeric and elastomeric materials are commonly encountered during the manufacturing process of pharmaceutical products and components of the packaging / container closure system.
During the product’s expected shelf-life and use, the constant contact and stressing may bring about a change in the composition of the product stored through interactions with its packaging.
Product packaging interaction studies focus on establishing this change in the product composition brought about by the interplay of packaging and stored content through means of molecular exchange. This exchange involves the solubilisation of compounds within the polymeric or metal matrix and their subsequent migration into the bulk of the stored product.
Elemental impurities according to Q3D guideline
Following the Q3D Guideline related to the control of the elemental impurities, QualiMetrix can provide a complete risk assessment, method development, validation and sample analysis for the determination of elemental impurities in final products and APIs by ICP-MS.
Filter validation studies
In accordance with the Parenteral Drug Association (PDA) technical report No 26/2008, QualiMetrix undertakes filterability, compatibility, and filter extractables tests, as well as bacterial challenge and viability tests as part of the filter validation activity.
In-vitro release testing and permeation studies
QualiMetrix performs in-vitro release (IVR) testing for semisolid preparations according to the provisions of USP General Chapter <1724> Semisolid Drug Products Performance Tests by using Franz diffusion cell, as well as in-vitro permeation (IVP) studies with human skin by following robust and discriminating analytical methodology.
Reverse engineering studies
QualiMetrix’s reverse engineering studies determine the composition of a reference pharmaceutical product to develop an essentially similar product.
Reliable and accurate determination of excipients is performed and a quantitative product composition is provided.
Identification of unknown impurities
QualiMetrix provides structural elucidation of unknown compounds using accurate mass measurements through high-resolution mass analysers (HRMS) that that leads to the highest confidence of the proposed structure.
The toxicological evaluation is performed with in-silico methodologies such as DEREK NEXUS software. The study is based on scientific literature and bacterial reverse mutation tests.
QualiMetrix provides high-quality reports, regulatory consultations, data gap analysis, scientific advice relating to the European Medicines Agency (EMA) or national agencies.
Qualiemtrix is a customer-driven laboratory that employs the Six Sigma philosophy to design and implement optimised processes with the aim of transforming customer inputs and requirements into customer value.
As such, the first and probably the most critical factor for a successful project is its proper definition in terms of both customer and technical requirements. To this end, a comprehensive study request form is provided to the customer with the following objectives:
- The definition of the type and scope of the study
- The provision of critical product information
- The determination of the most suitable, expedient and cost-effective approach
The word biocompatibility refers to the interaction of a living system or tissue with a finished medical device or component materials.
Extractables are organic and inorganic chemical entities that can be released from a test article and into an extraction solvent under laboratory conditions.